GMP Clearances: Timeframes for transfers and name change applications

Recently we have experienced an increase in administrative change requests, either to change manufacturer name and minor address details or to transfer clearances between sponsors. This increase combined with the overall rise in applications received has resulted in us prioritising assessments of GMP Clearances over administrative changes. We will endeavour to action your transfer request or name change application within a reasonable timeframe, however request patience during this period.

Transfer of sponsorship of GMP Clearances

While we aim to process simple transfer requests (less than five GMP Clearances) within 10 working days, where all documentation is provided, including full contact information of the new sponsor contact person, where larger transfer requests are submitted, these requests will take longer to action.

To assist us in resource allocation we ask sponsors to provide advice regarding proposed transfers as early as possible. Where a significant number of transfers are requested, that is more than 30, we ask sponsors to identify which clearances are the most critical ones for transfer and to provide an indication of timeframes when they will require the transfer to be completed to allow product regulatory actions to be undertaken.

We will endeavour to consider these timeframes, however, we may need to seek additional time for large transfer requests. Please be aware it may take several months for the transfers to be completed.

Name change applications

We have received enquiries regarding timeframes for name change applications. Where an application for a name change is received, we are required to contact other sponsors before actioning the request. We do not have set timeframes for actioning name changes as the time taken will vary depending on the number of sponsors involved and the number of ARTG entries to be updated. Please note, we are only able to update ARTG entries with current GMP Clearances. If your ARTG entry lists an expired GMP Clearance, you will need to request that this be updated through a product variation application.